Effectiveness of Mindfulness After a Stroke

NCT05029193 | Completed

• 1 other identifier: UP-20-00568-P2
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Mindfulness is promising for individuals with neurological disorders and caregivers to improve psychological well-being. This study aims to determine the extent to which a 3-week online mindfulness intervention will improve quality of life and psychological well-being for chronic stroke survivors and their caregivers, compared to a waitlist control.

Conditions

Stroke; Caregiver Burnout

Keywords

mindfulness; rehabilitation; caregiver; attention to variability

Outcome Measures

Primary Outcomes (3)

• Change from baseline on the Hospital Anxiety and Depression Scale (HADS)

  The HADS assesses depression and anxiety. It is a 14-item scale with 7 items each for anxiety and depression subscales. Each item is scored from 0 to 3, with higher scores indicating higher anxiety or depressive symptoms.

  2 months

• Change from baseline on NIH Toolbox Perceived Stress Survey (PSS)

  The PSS assesses perceived stress. It includes 10 items about the occurrence of life stressors scored from 0 (never) to 4 (very often). Higher scores indicate higher perceived stress.

  2 months

• Change from baseline on Single-item Sleep Quality Scale (SQS)

  The SQS assesses sleep quality and includes an 11-point visual analogue scale about sleep quality in the past week (0: poor, 10: excellent sleep quality).

  2 months

Secondary Outcomes (4)

• Change from baseline on Stroke-specific Quality of Life (SS-QOL)

  2 months

• Change from baseline on World Health Organization Quality of Life-BREF (WHOQOL-BREF)

  2 months

• Change from baseline on Zarit Burden Interview

  2 months

• change in the modified Ashworth Scale (elbow)

  2 months

Study Arms (4)

Stroke survivors - Mindfulness intervention

EXPERIMENTAL

Participants who have had a stroke who are receiving the mindfulness intervention immediately after enrollment (no wait period).

Behavioral: Langerian mindfulness

Stroke survivors - Waitlist control

NO INTERVENTION

Participants who have had a stroke who are assigned to the waitlist.

Caregivers - Mindfulness intervention

EXPERIMENTAL

Participants caring for someone who have had a stroke and receiving the mindfulness intervention immediately after enrollment (no wait period).

Behavioral: Langerian mindfulness

Caregivers - Waitlist control

NO INTERVENTION

Participants caring for someone who have had a stroke assigned to the waitlist.

Interventions

Langerian mindfulness BEHAVIORAL

A 3-week Langerian mindfulness intervention will be offered entirely online. The purpose of the intervention is: 1) to increase participants' mindfulness, and 2) to encourage participants to change their beliefs about the disability associated with stroke to improve their psychological state. Mindfulness refers to the act of being aware: aware of thoughts, aware of emotions, aware of physical sensations, aware of others. The intervention consists of educational texts, daily exercises, audio recordings and videos. Five different topics related to mindfulness will be introduced throughout the intervention.

Caregivers - Mindfulness intervention; Stroke survivors - Mindfulness intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants will not be excluded based on gender.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke survivor or caregiver of someone who have had a stroke
• Fluent in English
• Have access to Internet using a computer, a tablet and/or a smart phone.

You may not qualify if:

• Severe language impairments
• Participation in regular meditation or a mindfulness program in past 3 months

Sponsors & Collaborators

• University of Southern California: lead
• Harvard University: collaborator
• Chapman University: collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

MeSH Terms

Conditions

Stroke; Caregiver Burden

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Carolee Winstein, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All outcome measures are self-reported measures administered via online surveys, except for one. The person performing the data analysis will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to a mindfulness intervention or a waitlist control. Participants in the waitlist control group will receive the intervention after a 2-month waiting period.

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 31, 2021
• Study Start: September 13, 2021
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The documents will be uploaded by October 2021.

Locations

US (1)